Effects of Sulfur Water and Mud Therapy on Serotonin Activity and Biochemical Parameters in Patients' Osteoarthrosis

Not Applicable

• Conditions: Osteoarthritis of Multiple Joints
• Interventions: Other: Mud therapy application; Other: Sulfur water application; Other: Hygienic water

• Registration Number: NCT04192162
• Lead Sponsor: Specialized Rehabilitation Hospital Banja Koviljaca

Brief Summary

This study is to examine the effects of sulfur bath and mud therapy on serotonin levels and other biochemical parameters in the blood of the osteoarthritis patients, as well as water the application of exercise in water effects the results we receive.

Detailed Description

Sulfur baths and mud packs are known to have a positive effect in patients with osteoarthritis (OA). OA is a chronic degenerative disease accompanied by a constant pain that often leads to changes in the mood of patients. Over the last few decades, numerous articles reported various beneficial effects of sulfur water and peloid therapeutic applications. Serotonin is one of the important neurotransmitters that have numerous functions such as regulation of body temperature, sleep, appetite, while its main function is reflected in controling of depression.

The aim of this study is to examine the effects of sulfur bath and mud therapy on serotonin levels and other biochemical parameters in the blood of the OA patients, as well as whether the application of exercise in water effects the results we receive.

Randomized controlled study included patients with hip and/or knee OA both sexes, randomized into two groups. The first group patients underwent sulfur balneotherapy and mud pack therapy. Patients in the second group had sulfur balneotherapy, mud pack therapy and exercise in hygienic water. The duration of spa therapy program was 12 days. Serotonin values, parameters of complete blood count, lipid status and inflammatory markers were analyzed before and after the therapy.

This study is expected to be another contribution to existing evidence and shed light on the mechanisms of beneficial effects of balneotherapy and mud therapy and whether addition underwater exercise would have extra therapeutic effects.

Study Timeline

• Study First Submitted: 2019-11-12
• Status Verified: 2019-12
• Study First Submitted QC: 2019-12-05
• Study First Posted: 2019-12-10
• Study Start: 2019-12-18
• Last Update Submitted: 2019-12-18
• Last Update Posted: 2019-12-20
• Primary Completion: 2020-04-18
• Study Completion: 2020-09-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

1. Ages of 50 - 65 , both sexes
2. Patients diagnosed with hip and / or knee OA without having used balneotherapy in the previous year
3. Patients who have not changed their medication in the last 2 months
4. Patients who have not received injections into the hip and / or knee joint in the last 6 months (PRP, Diprofos...)

Exclusion Criteria

1. Secondary hip and / or knee OA
2. Patients with MOA inhibitors, selective serotonin inhibitors, morphine, lithium and methyldopa in therapy
3. Visible disruption of hip and / or knee joint structures
4. Treatment of malignancy
5. Diseases of the heart, lungs, decompensated conditions of other organs, infections, active bleeding
6. Severe hip and / or knee joint injuries, fractures, and previous surgical procedures
7. Physical therapy, balneotherapy back one year

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group of sulfur balneotherapy, mud pack therapy and exercise	Hygienic water	Control group of patients had mud pack therapy, sulfur balneotherapy and exercise in hygienic water. This group is a hydro group. From the blood of patients we analyzed parameters od complete blood count, serotonin values, lipid status and inflammatory markers before and after the therapy.
Group of sulfur balneotherapy and mud pack therapy	Mud therapy application	Experimental group patients underwent sulfur balneotherapy and mud pack therapy. The duration of spa therapy program was 12 days.From the blood of patients, serotonin values, parameters of complete blood count, lipid status and inflammatory markers were analyzed before and after the therapy.
Group of sulfur balneotherapy, mud pack therapy and exercise	Mud therapy application	Control group of patients had mud pack therapy, sulfur balneotherapy and exercise in hygienic water. This group is a hydro group. From the blood of patients we analyzed parameters od complete blood count, serotonin values, lipid status and inflammatory markers before and after the therapy.
Group of sulfur balneotherapy and mud pack therapy	Sulfur water application	Experimental group patients underwent sulfur balneotherapy and mud pack therapy. The duration of spa therapy program was 12 days.From the blood of patients, serotonin values, parameters of complete blood count, lipid status and inflammatory markers were analyzed before and after the therapy.
Group of sulfur balneotherapy, mud pack therapy and exercise	Sulfur water application	Control group of patients had mud pack therapy, sulfur balneotherapy and exercise in hygienic water. This group is a hydro group. From the blood of patients we analyzed parameters od complete blood count, serotonin values, lipid status and inflammatory markers before and after the therapy.

Primary Outcome Measures

Name	Time	Method
The serotonin levels	Time Frame: Baseline vs. 12-days	Serotonin concentration

Secondary Outcome Measures

Name	Time	Method
Analysis of hemoglobin	Time Frame: Baseline vs. 12-days	Concentration of hemoglobin (g/L)
Marker of inflammation	Time Frame: Baseline vs. 12-days	Sedimentation concentration
Analysis of red blood cell counts	Time Frame: Baseline vs. 12-days	The total number of erythrocytes / L

Trial Locations

Locations (1)

Specializd Rehabilitation Hospital Banja Koviljaca; 🇷🇸 Loznica, Banja Koviljaca, Serbia